A Phase 1 Study of SYNCAR-001 + STK-009 Without Conditioning Chemotherapy (Lymphodepletion) in Subjects with Severe, Refractory Systemic Autoimmune Rheumatic Disease

Description

This is a phase 1 study of SYNCAR-001 + STK-009 in patients with severe, refractory systemic autoimmune rheumatic disease.

Conditions

Systemic Lupus Erythematosus, Lupus Nephritis, Systemic Sclerosis

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Study Overview

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Study Details

Study overview

This is a phase 1 study of SYNCAR-001 + STK-009 in patients with severe, refractory systemic autoimmune rheumatic disease.

A Phase 1, Open-Label Study to Evaluate the Safety and Tolerability of a Combination Autologous CD19 CAR T Cell Therapy (SYNCAR-001 + STK-009) in Subjects with Severe, Refractory Systemic Autoimmune Rheumatic Disease

A Phase 1 Study of SYNCAR-001 + STK-009 Without Conditioning Chemotherapy (Lymphodepletion) in Subjects with Severe, Refractory Systemic Autoimmune Rheumatic Disease

Condition
Systemic Lupus Erythematosus
Intervention / Treatment

-

Contacts and Locations

Scottsdale

HonorHealth Research Institute, Scottsdale, Arizona, United States, 85258

Manhasset

Feinstein Institutes for Medical Research, Manhasset, New York, United States, 11030

Cleveland

The Cleveland Clinic Foundation, Cleveland, Ohio, United States, 44195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. History of or active central nervous system manifestations of autoimmune disease.
  • 2. Prior treatment with anti-CD19 adoptive T cell therapy, or any prior gene therapy product (e.g., CAR T cell therapy).

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Synthekine,

Study Record Dates

2041-04